Patches: The Middle Ground in Hemostasis Management
In today’s healthcare environment, it’s imperative to keep an eye on cost effectiveness while providing evidence-based care. In the cath lab, hemostasis patches are emerging as a low-cost alternative to closure devices and a complement to manual pressure.

Procoagulant materials

The use of vascular closure devices has found a niche in the cath lab, but they can’t be used on all patients or in all situations. In addition, patients staying overnight don’t necessarily need a costly device that will help them ambulate quickly. For cases when devices are not the choice, hemostasis patches are gaining acceptance.

Hemostasis patches, which contain various procoagulant materials, are placed over the femoral access site during manual compression.

Research presented by Daniela Trabattoni, MD, from Monzino Cardiology Center in Milan, Italy, at the Joint Interventional Meeting in Rome in February, found that the use of patches (QuickClot, Z-Medica) achieved hemostasis within five minutes from removal of the sheath and patients were able to walk within four hours. The data came from nearly 100 patients who were compared with manual compression alone. Patches were used in both diagnostic and interventional procedures, with sheath sizes ranging from 6F to 8F.

In the cath labs at Scott and White Heart and Vascular Institute in Temple, Texas, interventionalists use patches (Syvek NT, Syvek) about 30 percent of the time, for both diagnostic and interventional cases, says John P. Erwin, III, MD, senior staff cardiologist.

Guidelines suggest an activated clotting time (ACT) of less than 170 seconds as the cutoff for pulling the sheath and applying pressure. Some studies involving patches have used 250 seconds as the threshold, Irwin says, “which allows us to take a patient on blood thinners and remove the sheath sooner. That’s important because the sheath carries risk of injury. In addition, it’s more comfortable for the patient once the sheath is removed.”

Devices have various amounts of disruption of the artery itself, says Irwin. “I’m always cautious about putting something in the artery. If I can avoid it, I will. Patches offer that opportunity.”

ACT threshold

In 2008, Craig R. Narins, MD, and colleagues at the University of Rochester in New York conducted a prospective randomized study with 150 patients receiving either manual compression alone or manual compression with a patch (SafeSeal, Medrad Interventional/Possis). They found that the patch allowed for a significantly reduced time to hemostasis, as well as a one-hour difference to ambulation.

Researchers also randomized patients to either a higher ACT threshold of less than 250 seconds or a lower threshold of less than 170 seconds. They found that 73 percent of patients at the higher threshold treated with patches achieved complete hemostasis within 10 minutes, compared with 55 percent who received manual compression alone. The same was true regarding bed rest. The higher ACT threshold was associated with a significant reduction in bed rest compared with the lower threshold.

“Most patients, especially those with arthritis and back problems, find prolonged immobilization associated with bed rest uncomfortable. In addition, patients typically require closer monitoring during bed rest, which increases costs related to nursing staff time and effort,” the investigators wrote.

Because of the results of the study, cath lab personnel at the University of Rochester no longer wait until the ACT falls below 170 seconds to pull the sheath. They also have found that the use of bivalirudin (Angiomax, The Medicines Company) keeps the ACT above 250 seconds for one to two hours following PCI, “making sheath removal less likely.”

Nathan Richardson, RCIS, lead technologist at UPMC Mercy cath lab in Pittsburgh, Pa., uses a patch (SafeSeal) every time he manually pulls a sheath, between 30 and 40 percent of all cases. The use of a patch reduces compression time by half, he says, and “reduces bleeding complications after the sheath is out.”

Richardson says he has tried numerous types of patches with varying success, but the SafeSeal is the first one “to perceptively reduce hold times.”             

The use of devices has increased over the last several years and physician preference plays a big role in choosing the hemostasis method, Richardson says. There was a time when he’d pull eight sheaths in an evening; now it’s only a few. “Even so, you can’t spend 30 to 45 minutes with each patient performing manual compression alone. For optimal patient throughput, patches are a good option,” he says.